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Trial Title:
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL
NCT ID:
NCT05559450
Condition:
B-cell Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Blinatumomab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Blinatumomab
Description:
Blinatumomab will be bridged to conventional BUCY conditioning regimen.
Arm group label:
Blinatumomab arm
Intervention type:
Other
Intervention name:
Conventional therapy
Description:
Control group will be given conventional BUCY conditioning regimen.
Arm group label:
Conventional therapy
Summary:
To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic
Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
Detailed description:
High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor
prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to
Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute
Lymphoblastic Leukemia.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according
to the 2016 WHO classification) and are under hematologic remission.
2. ECOG score is 0-2.
3. Expecting life span is more than 6 months.
4. Patients are free from severe organ dysfunction.
Exclusion Criteria:
1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure:
ejection fraction(EF) <30%, NYHA standard, cardiac function not Full Grade II or
above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or
ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) >2.5mg/ dL or blood
Creatinine clearance rate < 30ml/min.
2. Patients are combined with infection or other complications that can not tolerate
chemotherapy.
3. Patients are suffering from central nervous system/solitary extramedullary leukemia.
4. Patients are considered as tumer progression.
5. Patients has undergone allogeneic hematopoietic stem cell transplantation or
underwent autologous stem cell transplantation within 6 weeks or other immunotherapy
within 4 weeks.
6. Pregnant and lactating women will not be included.
Gender:
All
Minimum age:
14 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang Zhang, PhD
Phone:
15606133002
Email:
zhangxiang@suda.edu.cn
Start date:
February 1, 2022
Completion date:
January 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
Zhongda Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Changzhou
Agency class:
Other
Collaborator:
Agency:
Wuxi People's Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wannan Medical College
Agency class:
Industry
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05559450
